Proactive Reduction of Outpatient Malpractice: Increasing Safety, Efficiency, and Satisfaction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the Proactive Reduction of Outpatient Malpractice: Increasing Safety, Efficiency, and Satisfaction (PROMISES) project is to assemble a high-level Massachusetts consortium to test the impact of powerful quality improvement techniques to accomplish innovations and improvements in high risk ambulatory malpractice areas. We will target problem-prone processes in 3 areas of identified risk: 1) medication management, 2) test ordering and results management 3) follow-up and referral management.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multi-Center Medication Reconciliation Quality Improvement Study

NCT01337063

Adverse Drug Events Medication Administered in Error

COMPLETED NA

Investigating the Impact of Mode of Administration on Item Response

NCT00783991

Chronic Obstructive Pulmonary Disease Depression Rheumatoid Arthritis

COMPLETED

Partnership in Resilience for Medication Safety (PROMIS)

NCT05880368

Patient Engagement Patient Empowerment Patient Activation

COMPLETED NA

Electronic Pharmacotherapy Risk Management

NCT00828490

Asthma Mental Health Pain

COMPLETED

Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety

NCT00256568

Medication Errors

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Reducing medical malpractice in ambulatory care represents a priority area that has been relatively neglected in the face of more dramatic and costly inpatient errors. Given shifts in care, increasing stresses on office practices, growing evidence of unreliable office processes, and recent experience of our malpractice insurance carriers, neither complacency nor resignation to the problems of ensuring safe patient-centered office care can be justified. Working with the two leading malpractice insurers in Massachusetts, we have assembled a consortium to improve patient safety and decrease malpractice risk in ambulatory practice-the Proactive Reduction in Outpatient Malpractice: Improving Safety, Efficiency and Satisfaction (PROMISES) project. We work with leading quality improvement and safety experts to employ state-of-the art approaches and tools to achieve breakthrough changes in demonstration practices. The project has the following three specific aims:

AIM 1. Apply evidence from malpractice claims to identify key failure modes contributing to ambulatory medical errors and malpractice suits in order to redesign systems and care processes to prevent, minimize, and mitigate such errors in a group of Massachusetts primary care practices. We will target problem-prone processes in 3 areas of identified risk: 1) medication management, 2) test ordering and results management 3) follow-up and referral management.

AIM 2. Transform communication culture, processes and outcomes in demonstration practices to become more patient and family-centered, particularly around proactively seeking out, hearing, handling, and learning from patients' safety experiences, concerns and complaints.

AIM 3. In conjunction with key Massachusetts policy leaders, liability insurers, clinical, academic, quality improvement and consumer organizations, we will evaluate and disseminate the lessons learned and share successful intervention tools and strategies statewide with a broader audience of practices, practitioners, payers, and policy makers. The intervention would be designed as a randomized control trial comparing 16 demonstration practices with 9 control practices, each with 2-5 primary care providers recruited by the malpractice insurers. We will measure the effects of the improvement efforts using rigorous quantitative and qualitative data from staff interviews, patient surveys and chart review. We will then spread the successful tools, improvements, and lessons statewide.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medical Malpractice Patient Safety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Improvement Sessions

We will implement a context-sensitive collaborative improvement model that will emphasize training and in-office coaching by quality improvement, efficiency and safety experts, as well as shared learning methods to develop, test and implement changes in the following four key risk areas: medication management; test and lab results management; follow-up and referral management; and communication - within and between practices as well as with patients.

Group Type EXPERIMENTAL

Training and in-office coaching

Intervention Type OTHER

Participating practices will be coached to perform rapid, small-scale tests of change and to iteratively improve performance of problem-prone care systems, as well as to imbed simple measurement in routine daily work streams to guide improvement efforts. The sixteen intervention practices will serve as realistic research laboratories to help advance malpractice risk prevention and patient safety in specific areas by refining tools and strategies for smaller practices.

Control

Control practices will not receive training or in-office coaching.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Training and in-office coaching

Participating practices will be coached to perform rapid, small-scale tests of change and to iteratively improve performance of problem-prone care systems, as well as to imbed simple measurement in routine daily work streams to guide improvement efforts. The sixteen intervention practices will serve as realistic research laboratories to help advance malpractice risk prevention and patient safety in specific areas by refining tools and strategies for smaller practices.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary Subjects: staff members of small to medium-sized primary care (internal medicine or family medicine) practices in Massachusetts with adult, English-speaking patients.
* Secondary Subjects: English-speaking adults who receive care at an enrolled intervention or control office practice.